This document discusses emulgels, which are a novel drug delivery system. Emulgels are a mixture of an emulsion and gel that have advantages over other topical formulations. Emulgels allow for delivery of both hydrophilic and hydrophobic drugs to the skin through a dual release mechanism. They provide properties like being greaseless and having a long shelf life. The document reviews the components, properties, formation, and characterization of emulgels. It also discusses emulsions and gels separately as the components of emulgels. Emulgels are useful for delivering analgesics, anti-inflammatories, antifungals, and anti-acne drugs through the skin.
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SR no Brand name Active Ingredient Manufacturer Uses
1
Voltarol 1.16%
emulgel
Diclofenac Diethyl
Ammonium nitrate
Novartis Anti- inflammatory
2
Miconaz – H-
emulgel
Miconazole nitrate
Hydrocortisone
Medical union
pharmaceuticals
Topical corticosteroid,
Antifungal
3
Denacine
emulgel
Clindamycin Phosphate
Beit Jala pharmaceutical
company
4 Diclon emulgel
Diclofenac
Diethylamide
Med pharma
Anti-
inflammatory
5 Catalan emulgel Diclofenac potassium Novartis Anti- inflammatory
It is used to treat acne, pains colds, headaches,
muscles, backaches, and arthritis
EMULSION
Emulsion are the phases of two or more immiscible
liquids and the one phase is dispersed into dispersed
medium. The various types of emulsions are prepared
for stability of the formulation and emulsifier is
necessary.
The different types for emulsion are oil in water
emulsion, water in oil emulsion, oil in oil emulsion,
multiple emulsion and microemulsion. There are the
various factors which affect the
process of emulsion such as concentration of
emulsifier, temperature, nature of oil and emulsifier.
Emulsion is defined as the biphasic system consisting
of two immiscible liquids, is the dispersed phase is
finely and uniformly distributed as globules
throughout the continuous phase. The emulsion is
thermodynamically stable and it is stabilized by the
emulsifier. Emulsifier stabilizes the system by
forming a thin film around the globules of dispersed
phase. The dispersed phase or continuous phase may
vary in consistency. The pharmaceutical emulsion
may range from low viscosity to high viscosity. The
particle size range of dispersed phase may range from
0.1 to 100 micrometer.
TYPES OF EMULSION:
Oil in water emulsion
Water in oil emulsion
Multiple emulsion
Microemulsion
Pickering emulsion
Oil in water emulsion:
The pharmaceutical emulsions generallyconsist of the
aqueous phase with various oil phase and waxes. If the
oil phase is dispersed throughout the aqueous phase,
the emulsion is termed as oil in water emulsion (O/W)
emulsion. They are non greasy and easily removable
from the skin surface. They are used externally for
cooling effect and internally to mask the bitter taste of
drug.
Water soluble drugs are most commonly released
from O/W emulsion. They show positive conductivity.
Water in oil emulsion:
This is a system in which the water globules are
dispersed in a oil continous phase and it is termed as
W/O emulsion. They normally show occusive effect
by hydrating the stratum corneum. It is also used for
the cleansing of skin of oil soluble dirt. They are
greasy and water washable and generally used to
avoid evaporation of moisture from the surface of the
skin. Oil in external phase is a poor conductor of the
electricity.
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Multiple emulsions:
They are the complex systems. They are generally the
Emulsion of emulsions. It is a complex type of system
in which the o/w or w/o emulsion are dispersed in
another liquid medium. The application for multiple
emulsion generally consists of the taste masking,
adjuvant vaccines, sorbent resorvoir of overdose
treatments, and also the augmentation of skin. It can
be formulated as the cosmetics such as skin
moisturizer. Prolonged release can be formulated
using the multiple emulsions.
Microemulsion:
These are the systems consisting of water oil and
surfactant. These types of emulsions are suggested by
Hoar and Schulman. There are mainly two types of
emulsions: O/W and W/O microemulsion. This
process is generally emulsion-gel-emulsion.
Pickering emulsion:
These are the type of emulsion in which solid phase
are the emulsion stabilizers. It has recently
applications in cosmetics, food, pharmaceuticals, oil
recovery and waste water treatment.
General method for emulsion:
General method
Phase inversion method
Continental and dry gum method
Wet gum method
Membrane emulsification method
General method: These are the O/W emulsions
which are prepared by dividing the oily phase in
minute globules with the use of the envelope of
emulsifying agent and finally suspends
globules in the aqueous phase. The W/O emulsion
process is converse process. The W/ O emulsion is
generally prepared by dividing the aqeous phase
completely in the minute globules surrounding each
by emulsifying agent envelope and finallysuspending
in the oily phase.
Phase inversion method: In the following method,
the aqeous phase is first added to the oil phase so as to
form a W/O emulsion. At the inversion point, the
addition of more water results in inversion of
emulsion that is the formation of O/W emulsion.
Continental and dry gum method: This method is
generally used for the preparation of
extemporaneously emulsion. The preparation of
emulsion is generally bymixingthe emulsifyingagent
usually acacia with the oil and then the mixing with
the aqueous phase. Continental and dry gum method
generally differentiate in the proportion of
constituents.
Wet gum method: In this method, the proportion of
constituents remain same as dry gum method, the
difference is just in the method of preparation.
Mucilage of acacia is used as a emulsifyingagent. The
oil is added to the mucilage drop by drop with
continuous trituation
Membrane emulsification method: It is based on
the novel concept of the generating droplets
“drop by drop” to produce emulsion. The pressure is
directlyappliedtothedispersedphase.
Stability of emulsion
Coalescence
Flocculation
Creaming
Breaking
Flocculation: It is the association of the small
emulsion particles to form large aggregate which is
redispersible upon shaking. It is a reversible process in
which the droplets remain intact. The flocculation and
emulsion droplets by excess surfactant occur because
of the depletion effect. Flocculation is also called as
the precursor of the coalescence.
Creaming: It is the phenomenon in which the
dispersed phase separated out, forming a layer on the
top of th continuous phase. The conclusion is that the
dispersed phase remains in globule state and it can be
redispersed on shaking. It is generally reduced by
increase in viscosity
Coalescence: A more subtle type of emulsion
instability occurs when the mechanical or electrical
barrier is insufficient to prevent the formation of the
large droplets.These can be prevented by addition of
high boiling point or the high molecular weight to the
continuous phase.
EVALUATION OF EMULSION
Viscosity: Cone and rotational viscometer can be
used with spindle fibers can be used to measure
the viscosity.
PH: pH could be measured using digital pH
meter.
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Drug Content: suitable dilution of drug loaded
emulsion is made and concentration could be
measured by UV visible spectroscopic method in
nm by keeping the reagent blank.
Centrifugation: This is used to measure the
physical stability. The emulsion is generally
evaluated at the ambient temperature and 5000
rpm to observe the creaming or the phase
separation.
Dilution Test: In these method continuous phase
is added to the emulsion, it could not be separated
into So repeated dilution is done 50 – 100 times
to check the phase separation or creaming.
Zeta Potential & Micelle Size Analysis: micelle
size, size distribution and Zeta potential can be
measured using particle size analyzer
Diffusion: By D – cell at 37 degree Celsius using
rate skin as membrane
Microbial Study Of Emultion: Ditch plate
technique is used for bacteriostatic and fungistatic
activity
%Inhibition: Length of inhibition / whole length
×10
GELS
It is mainly constituted of the entrapment of large
amounts of hydroalcoholic or aqueous in the network
of the colloidal particles with the use of polymers.
Gels are defined as the semi rigid system in which the
movement of the dispersing medium is restricted by
an interlacing three - dimensional network The
polymers may be natural, synthetic, inorganic or
organic. The higher aqueous content permits greater
dissolution of drug these makes gel poor vehicle for
hydrophobic drugs. The limitations of gel can be
overcomed by emulgel.
TYPES OF GELS:
Based on the colloidal phases:
Inorganic Gels
Organic Gels
Inorganic Gels: It is a two phase system. The
partition size of the dispersed phase is relatively large
and form a three dimensional structure throughout the
gel. It consists of floccules of small particles rather
than the larger molecules and gel structure. They are
the thixotropic forming semisolid on standing and
become liquid on agitation.
Organic Gels: It is a single phase system. These
system consists of large organic molecules existingon
twisted strands dissolved in a continuous phase. The
large polymers are generally referred as the gel
formers, they tend to entangle with each other or
bound by Vander waals force
Based on the nature of solvent:
Hydrogels: A hydrogels is a network of polymer
chains that are hydrophilic, infrequently found in
the colloidal gel in which water is a dispersion
medium. They are highly absorbent natural or
synthetic polymeric networks.
Organogels: An organogels is a non – crystalline,
non- glassy thermo reversible solid material
composed of liquid organic phases trapped in the
3D cross- link network. The liquid used can be
vegetable oil, an organic solvent, mineral oil.
Xerogels: It is a solid formed from a gel by
drying with unrestricted shrinkage. It is frequently
retains high porosity and huge surface area and
along with small pore size. When the solvent is
removed in supercritical conditions, the network
doesn’t shrink and a highly porous, low density
material known as aerogel is produced. The high
treatment of xerogel at higher temperature
produces viscous sintering and transforms the
porous gel into thick glass.
Based on rheological properties
Plastic gels: flocculated suspension of Aluminum
hydroxide exhibit a plastic flow and the plot of
rheogram gives the yield value of gels above
which the elastic gel disortsand begins to flow
Pseudo-plastic gels: Liquid dispersion of
Tragacanth, sodium alginate, Na CMC, exhibit
pseudo-plastic flow. The viscosity of gels
decreases with the increasing rate of shear,with no
yield value
Thixotropic gels: The bonds between the
particles in these gels are very weak and broken
down by shaking. The resulting solution will
reverse back to gel due toparticles colloiding and
linking together again. These is also called as
reversible isothermal gel- sol-gel formation. It
forms scaffold like structure.
Based on physical nature:
Elastic gels: Gels of agar, pectin, Guar gum and
alginates exhibit an elasticbehaviour. The fibrous
molecules being linked at the point of junction by
hydrogen bonds. E g Alginate and Carbapol
Rigid gels: This can be formed from
macromolecule in which the framework is linked
by primary valence bonds.
Preparation of Gels:
Thermal changes: Solvated polymers when subjected
to thermal change cause gelatin. Many hydrogen
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formers are more soluble in hot water than cold water.
Cooling of a concentrated hot solution will produce a
gel. Some materials like cellulose have their water
solubility in water.
Hence these method is not used to prepare gel as a
general method.
Flocculation: In these method, gelatin is produced
just by adding sufficient quantity of salt to produce
age state, but it is not able to produce complete
precitipitation. It is important to ensure that there is a
quick mixing to avoid high precitipitation. The gels
formed by flocculation method are thixotropic in
nature. Hydrophilic colloids such as gelatin, proteins
and acacia are affected by high concentration of
electrolytes. In salt out effect, the gelatin and colloidal
doesn’t occur.
Chemical reaction: In these method, gel is produced
by chemical interaction between the solute a and
solvent. E.g Aluminum hydroxide gel can be prepared
by chemical interaction between the aluminum salt
and sodium carbonate. An increased concentration of
reactants will produce a gel structure
Evaluation of parameters for Formulated Gels:
Measurement of pH: The measurement of pH is
done by digital pH meter. Dissolve 1 gm of gel
with 100 ml of distilled water and store for 2
hours. The measurement of pH is in triplicate
values.
Drug content: Mix 1g of gel with 100; ml of
suitable solvent. Filter the stock solution
The different concentrations by suitable dilutions
and measure the absorbance. Drug content was
calculated byequation which is obtained by linear
regression of calibration curve.
Viscosity study: It is carried using Brookfield
viscometer.
Spreadability: It indicates the extent of area to
which gel readily spreads on application to the
skin or affected part. The therapeutic potencyalso
depend upon the spreading value. S= M×L/T
M= weight tied to the upper side
L= length of glass slides.
T= Time taken to separate the glass
Extrudability study:: The formulations are filled
in the collapsible tube, after it was set in a
container. It is determined in terms of weight in
gm required to extrude a 0.5 cm ribbon of gel in
10 second.
Skin irritation study: The gel was applied twice
a day for seven days and the site was absorbed for
any sensitivity and the reaction if any.
In- vitro Diffusion studies: It can be carried out
at Franz diffusion cell, for studying the
dissolution release of gels through a cellophane
membrane.
In- Vivo studies: Inhibition of carrageenan
induced rat paw edema: 3 groups of 6 male
Wistar albino rats were used.
Stability: It was carried out at a freeze- thaw
cycling. The product is subjected to temperature
of 4 degree Celsius for 1 month, 25 degree
Celsius for 1 month and then 40 degree Celsius
for 1 month, Syneresis were observed.
Homogeneity: Set the gel in container and then it
is tested for homogeneity for visual inspection.
The presence of their appearance and presence of
aggregates weretested.
Grittiness: The formulations were evaluated
microscopically to check the presence of any
visible particulate matter which is observed under
light microscope.
Rheology
Solutions of the gelling agents and dispersion of
flocculated solids are pseudoplastic. They exhibit
Non – Newtonian behaviour. These are formed by the
decrease in viscosity and increase in shear rate. The
tennous structure of inorganic particles dispersed in
water is disrupted by applied shear stress due to
breaking down of interparticulate association,
showing great tendency to flow. For the
macromolecules, the applied shear stress aligns the
molecules in direction of stress straightening them,
and showing less tendency to flow.
Emulgel:
In comparison to other groups of semisolid
preparations, the use of gels is used mostly in the
cosmetics and pharmaceuticals. Despite of providing
several benefits the gel category has limitations of
delivering hydrophobic drugs. With these approach,
there is enhanced effect in release pattern of sustain
and control release. The presence of gelling agent
converts the classical emulsion into the Emulgel. The
use of emulgels can be expanded in analgesics, anti-
fungal, anti – acne drugs and various formulations.
Topical drug administration is simpliest and easiest
route of delivery by various routes in the body.
Topical delivery proves beneficial as it bypass the
first pass metabolism. Topical drug mainlyis used for
the fungal infection. Molecules van basically
penetrate into the skin through three routes: the
surface of the stratum corneum, through sweat glands,
through sebaceous follicle.
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Drug Delivery Across the skin:
The epidermis is the most superficial layer of the skin
and composed of stratified keratinized squamous
epithelium which varies in thickness in dfferent parts
of the body. It Is thickest which contains elastic
fibres. The skin forms a water proof layer which
protects the superficial layer. Blood vessels are
distributed beneath the skin. In most exposed areas,
the blood vessels are also distributed into small
arteries through highly muscular arteriovenous
anastomoses. The dermatological pharmacology is
direct accessibility to the skin as a target organ for
diagnosis and treatment. The skin acts as a two way
barrier system to prevent absorption to prevent
neither absorption nor loss of water and electrolytes.
There are three primary mechanisms of topical drug
absorption: transcellular, intercellular and follicular.
The most common path is the path through the
corneocytes through lipid bilayer to viable layers
through the skin. The next most common route is
through the pilosebaceous route
RATIONAL OF EMULGEL
Topical preparation generally has limitations of less
spreading, less penetration through stratum corneum,
less patient compliance due to stickiness and need to
apply with rubbing etc while the gels have the
limitations of delivering hydrophobic drugs. On the
other hand, emulgel is prepared by using emulsifier
and they are prepared by using selected oils so the
problem of the solubility is nearly overcomed. Less
dose of drug is required to obtain the pharmacological
action. Number of medicated products are applied to
the skin membrane that either restores the
fundamental function of skin or pharmacological
alters an action in the underlined tissues. These
products are referred as topical or dermatological
products. Many other topical formulations have
disadvantages such as they are sticky in nature
causing uneasiness to patient. With these
disadvantages, the use of novel approach as a
transparent gel is expanded bothin cosmetics and in
pharmaceutical preparations.
EVALUTION OF EMULGEL:
Physical Examination: The prepared Emulgel is
inspected visually for their color, homogeneity
and consistency and pH. The pH values of
Gellified emulsion is measured by pH meter.
pH: 1% solution in water of emulgel is subjected
to measure pH by digital pH meter.
Spreadability Measurement: 0.5 gm of emulgel
is placed on a glass slide and circle made around
it. Then the second slide is placed over it and
predetermined weight is kept for specific time
periods and then the increase diameter is to be
noted. It is measured by apparatus called
Multimer which his suitably modified in the
laboratory and used for study. It consists of the
wooden block, which is provided by a pulley at
one end. Bythis method, Spreadabilityisbasedon
the“Slip”and“Drag” method.
S= M. L×T
S= spreadability
M= Weight tied to the upper side L= length of glass
slides
T= Time taken to separate the slides completely from
each other.
Syneresis Measurement: On rest gel shrinks and
little liquid is pressed out called syneresis. these is
measured by using centrifuge tube.
Syneresis %= liquid separated from emulgel /
Total weight of emulgel before centrifugation
×100
Rheology Study: Viscosity can be measured
using rheometer. It is determined at 25 degree
Celsius using a cone and plate viscometer with
spindle 52 and connected to a thermostatically
controlled circulating water bath.
Drug Content Determination: Drug content can
be measured using official method in
pharmacopoeia.
Tube Test: It determines force necessary for
removal of emulgel from tube and is necessaryfor
extrudability.
Diffusion Study: By D cell at 37 degree Celsius
at rate skin.
Drug Release Kinetic Study: It can be studied
using Higuchi modeland various other models.
Microbial Assay Of Emulgel: Ditch plate
technique is preferred for microbial assay and
zone of inhibition is calculated
Optimization & Development Of Emulgel by
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suitable statistical development of design of the
experiment.
Skin Irritation Test: By Draize patch test in
rabbit.
Microbial Assay Of Optimized Batch: byDitch
plate technique.
Accelerated Stability Study Of Optimized
Batch: Batch Sample emulgel is sealed in
ampoules and then put in ambient temperature.
Chemical stability could be expressed as a content
of drug.
Globule size and distribution in emulgel:
Globule size and distribution is determined by
Malvern Zeta sizer. A 1.0 gm of drug is dissolved
in n purified water and agitated to get a
homogeneous mixture. Sample is filled in
photocell of zetasizer. Mean globule size and
distribution is obtained.
Swelling index: To determine the swelling index
of prepared topical Emulgel, 1 gm of gel is taken
in porous aluminium foil and then placed in 50 ml
separate beaker containing 10 ml 0.1 N NAOH.
ADVANTAGES & DISADVANTAGES OF
EMULGEL
Advantages:
Incorporation of hydrophobic drugs
Better loading capacity.
Avoidance of first pass metabolism.
Avoidance of gastrointestinal incompatibility.
Controlled release of the drug
More selective for specific site.
Production feasibility and low preparation.
Disadvantages:
Skin irritation on contact dermatitis
The poor permeability of some drugs through
skin.
The occurrence of bubble during formulation of
the emulgel.
Drug size of large particles is not easy to absorb
through the skin.
There is possibility of allergic reactions.
PREPARATION OF EMULGEL
Formulation of O/W or W/ O emulsions:
The initial step of formulation involves the
dissolution of oil – soluble substances in the oil
vehicle. E.g dissolving span 20 in liquid paraffin and
dissolution of the water soluble substances in n
aqueous vehicle.( e.g dissolving tween 80 in purified
water )both the phase were mixed at turbulent stirring
to ensure the dispersion of the two phase into
droplets.
Formulation of gel base: The water soluble
substances are dissolved in aqueous vehicle using
mechanical stirring. To avoid aggregation, the
hydrophilic polymer is added to stirred mixture
and stirring is continued until the polymer has
dissolved and the pH remains in the desired
range.
Addition of base into gel base with steady
blending: The gel stage is mixed into emulsion
stage to the extent of 1: 1 to get emulgel.
FORMULATION OF EMULGEL
For the preparation of emulgel, some of the following
constituents are used:
Vehicle: They should follow the ideal
characteristics
Aqueous Vehicle: The aqueous vehicles used are
water, alcohol etc
Oil: Oil used are mineral oils, paraffin or they are
used in combination.
Emulsifiers: Span 80, tween 80, stearic acid,
sodium stearate.
Gelling Agents: They enhance the consistency of
the preparation.
Penetration Enhancers: It helps to absorb the
drug through the skin.
pH adjusting agent
IDEAL PROPERTIES OF ADDITIVES:
They should be non- toxic.
They should be easily available.
They should be cheap.
They should not be contraindicated.
They should be physically and chemically stable.
GENERAL METHOD FOR PREPARATION OF
EMULGEL:
Emulgel is prepared by incorporating gel and
emulsion. The emulsion and gel are prepared
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separately and mixed together. The gel is prepared by
using gelling agent. After the preparation of both the
formulation
The chemicals used are the oil phase such as castor
oil, clove oil, liquid paraffin etc. Water and alcohol
are used as a aqueous phase. The aqueous phase is
prepared by mixing the tween 80 and water and the
oil phase is prepared by using the paraben and
propylene glycol. The drug is dissolved in ethanol
and two phases are mixed with the continuous stirring
and then the polymers are mixed with pH of 6.0 to
6.5. After preparation of gel and emulsion separately,
they are mixed to form emulgel
APPLICATION OF EMULGEL
The emulgels are generally used for the delivery of
analgesic, anti- inflammatory, anti- acne and
antifungal drugs.
They show generally favourable formulation of
hydrophobic drugs over the gel formulation.
It show control and better release of drug to be
incorporated in gel base to obtain a gelfilled
emulsion.
Emulgels shows control and better release by used of
combined effect of gel and emulsions.
Emulgel have certain advantages over gel and
emulsions such as thixotropic, greaseless, easily
spreadable, easily removable, emollient, long shelf
life, biofriendly transparent, and pleasant appearance.
FUTURE PROSPECTS:
The nano emulgel drug delivery system is a
formulation to improve the systemic delivery and
therapeutic profile of lipophilic drugs. Nanoemulgel
is a mixture of two different systems in which
nanoemulsions drugs are incorporated into the gel
ase. Lipophilic drugs can be easily formula d and
enhancement of skin permeability by several folds of
droplets due to nthe anoemulsions phase. Also the
pharmacokinetics apharmacodynamicsmic are
significantly increased.
PATENT ABILITY:
An increasing trend in topical nanoemulgel use in
recent years has been noticed due to their better
acceptability due to their invasive delivery, avoidance
of gastrointestinal side effects, easier applicability,
and good therapeutic profile. Nanoemulgel has
considered a promising formulation and has great
potential for drug delivery. The hydrophobic drugs
are also formulated using emulated as novel drug
delivery.
CONCLUSION
The topical drug delivery system will be extensively
used due to better patient compliance. Emulgel
possesses an edge in terms of spread ability, adhesion,
viscosity, and extrusion. They contain a solution to
deliver hydrophobic drugs in water-soluble gel bases.
Emulsion topical dosage form is generally used in
addition to dermatology pharmacotherapy. Many
researchers have concluded that the emulgels area
novel drug delivery system fthe or local and systemic
site of action.
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